72 Participants NeededMy employer runs this trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, CX-011, to determine if it can safely and effectively reduce knee pain from osteoarthritis. Osteoarthritis often causes pain during long walks but improves with rest. The trial includes several groups: some will receive different doses of CX-011, while others will receive a placebo (a pill with no active ingredients). Individuals who have experienced knee osteoarthritis pain for over three months and have tried at least three unsuccessful treatments may be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CX-011 is generally safe. Studies indicate that this drug primarily remains in the knee where administered, minimizing its spread to other body parts. This reduces the likelihood of side effects elsewhere. Tests revealed that patients tolerated various doses of CX-011 well, suggesting overall safety. The data reports no major side effects, indicating that CX-011 could be a safe option for those seeking new ways to relieve knee osteoarthritis pain.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for knee osteoarthritis, which typically include pain relievers like NSAIDs or corticosteroid injections, CX-011 offers a novel approach. Researchers are excited about CX-011 because it targets the underlying inflammation and cartilage degradation in the knee joint more directly. This treatment is being tested in different doses, which could help in finding the most effective way to manage symptoms while minimizing side effects. Additionally, the potential for CX-011 to deliver longer-lasting relief with fewer doses sets it apart from current options, offering hope for improved quality of life for patients.

What evidence suggests that CX-011 might be an effective treatment for knee osteoarthritis?

Research has shown that CX-011 may help treat knee osteoarthritis. Early studies found that CX-011 reduces pain and swelling while protecting and repairing cartilage in the joints. This drug targets the main causes of joint damage, such as ongoing inflammation and immune system problems, common in osteoarthritis. Animal tests demonstrated that CX-011 effectively manages pain and reduces swelling. Overall, these findings suggest that CX-011 could be a useful treatment for easing knee pain and slowing joint damage in osteoarthritis.12346

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to under 75 with moderate to severe knee osteoarthritis pain that hasn't improved after trying at least two other treatments. Participants must have X-ray evidence of knee arthritis, ongoing pain most days, and a BMI under 40.

Inclusion Criteria

Written consent to participate in the study
I am between 18 and 75 years old.
Willing to agree not to use illicit drugs during study and to have illicit drug testing at screening and if suspected during study
See 10 more

Exclusion Criteria

Participation in another clinical trial within 30 days before screening or planned participation during study
I have had a steroid injection in my knee within the last 3 months.
I have major birth defects or abnormal tissue growths.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular administration of CX-011 at varying doses to assess safety and tolerability

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 4, 12, and 24 weeks post-injection

24 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CX-011

Trial Overview

The study is testing CX-011, a drug injected directly into the affected knee joint, to see if it safely reduces pain in people with moderate to severe knee osteoarthritis who haven't responded well to standard therapies.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: CX-011 medium doseExperimental Treatment1 Intervention
Group II: CX-011 low doseExperimental Treatment1 Intervention
Group III: CX-011 high doseExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CarthroniX, Inc.

Lead Sponsor

Citations

NCT07308834 | Evaluation of Intra-articular CX-011 to ...

Study is designed to evaluate the safety and effectiveness of a drug called CX-011 to treat pain in patients with osteoarthritis of the knee.

Evaluation of Intra-articular CX-011 to... | Clinical Trial

Efficacy endpoints include changes from baseline in pain intensity measured at 4, 12, and 24 weeks post-injection, as well as percentage ...

Safety, Tolerability and Clinical Development of CX-011

Preclinical studies have demonstrated that IA CX-011 reduces pain, curbs synovial inflammation and promotes cartilage preservation and regeneration.

Potential relief for osteoarthritis moves to clinical trial after ...

The animal model studies showed that the drug compound can disrupt the receptor's over-activation of inflammation, and still manage pain and ...

Novel Small Molecule Modulator of the gp130 Receptor ...

Conclusion: Taken together, these data suggest efficacy in controlling joint disease progression and its symptoms as well as a good safety profile for CX-011.

R805/CX-011 could be osteoarthritis treatment breakthrough

USC researchers uncover a potential osteoarthritis treatment breakthrough with drug compound R805/CX-011 that promises to relive pain.